- Two Phase 3 clinical trials, SIMPLIFY-1 and SIMPLIFY-2, assessing Gilead Sciences' (NASDAQ:GILD) Janus kinase (JAK) inhibitor momelotinib compared to ruxolitinib [Incyte's (INCY) Jakafi] or best alternative therapy (BAT) in patients with myelofibrosis produced different outcomes.
- SIMPLIFY-1 met its primary endpoint of non-inferiority to ruxolitinib for splenic response rate at week 24 (SRR24) defined as the percentage of patients achieving at least a 35% reduction in spleen volume (momelotinib: 26.5%; ruxolitinib: 29.0%; p=0.011).
- SIMPLIFY-2 failed to meet its primary endpoint of superiority compared to BAT in patients previously treated with ruxolitinib as measured by SRR24 (momelotinib: 6.7%; BAT: 5.8%; p=0.90). 88% of the patients randomized to the BAT arm continued to receive ruxolitinib while the remainder received chemo, interferon, corticosteroids, other therapies or a combination thereof.
- Detailed results will be presented at a future scientific conference.
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